Kornimate/medical-research-clean huggingface dataset:
study to assess the effect of the nexthaler® device (dpi - dry powder inhaler) on the central and peripheral airway dimensions in asthmatic patients

Conditions: Asthma

Summary: the objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate in a dry powder inhaler (nexthaler®) on central and peripheral airway dimensions in asthmatic patients. therefore computational fluid dynamics (cfd) will be used. further more, the effect of this combination therapy on lung function (spirometry, resistance and diffusion), the asthma control test (act™) and the asthma control questionnaire (acq) will be assessed and the safety will be evaluated.


Eligibility criteria:
inclusion criteria: 1. patients with moderate asthma as defined by the current gina guidelines. patients can belong to 2 categories: group 1 (n=15 to 20, at least 4 current smokers): patients not well controlled (partially controlled or uncontrolled according to the gina guidelines) when using medium daily dose of ics or medium dose ics + long acting inhaled 2-agonists (laba) (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine). group 2 (n=15 to 20, at least 4 current smokers ): patients well controlled (according to gina guidelines) when using medium daily dose of ics + laba (for definition please refer to the addendum in section 15) given for at least 6 weeks as large-particle formulation (non extra-fine). 2. male or female patients aged ≥18 years 3. patients with a documented diagnosis of asthma according to the gina guidelines 4. patients with a co-operative attitude and ability to be trained to correctly use the foster nexthaler dpi 5. written informed consent obtained exclusion criteria: 1. patients treated with extra-fine ics either alone or with laba 2. pregnant or lactating females or females at risk of pregnancy at screening and not willing to use an appropriate contraception method during the study period 3. inability to carry out pulmonary function testing 4. history of near fatal asthma 5. hospitalization due to asthma or symptomatic infection of the airways in the previous 8 weeks 6. patients with an uncontrolled disease or any condition that might, in the judgement of the investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study 7. cancer 8. current alcohol or drug abuse 9. allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients 10. patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study 11. patients who received any investigational new drug within the last 4 weeks prior to the screening visit 12. patients treated with any non-permitted concomitant medication

Keywords: asthma nexthaler® formoterol beclomethasone dipropionate computational fluid dynamics functional imaging central and peripheral airways asthma control test (act™) asthma control questionnaire (acq)
hypertonic saline resuscitation in trauma patients after hemorrhage control

Conditions: Abdominal Injuries

Summary: this study aimed to determine whether hypertonic saline solution is effective in the resuscitation of injured patients undergoing abdominal damage control surgery regarding early closure of the abdominal wall.

a double-blind, controlled, randomized clinical trial was conducted to determine the impact of an infusion of hypertonic saline 3% vs. isotonic saline 0.9% at a dose of 50 ml/hr for the first 72 hours in patients with abdominal trauma requiring damage control surgery regarding some clinically relevant outcomes. these outcomes were: the timing of abdominal cavity closure, fluids balance, abdominal hypertension, and abdominal compartment syndrome occurrence, organ dysfunction, and 28 days' mortality.

Eligibility criteria:
inclusion criteria: * abdominal trauma requiring damage control surgery. * acceptance by the patient or by a proxy to be included in the trial. exclusion criteria: * concomitant severe head trauma, defined by a glasgow score \<9, before receiving sedation or by the presence of cerebral edema or intracranial injury on a ct-scan. * pregnancy * patient not included 4 hours or more after damage control surgery. * damage control laparotomy performed for other indications other than trauma. * not index damage control laparotomy * no acceptance to participate in the study.

Keywords: open abdomen hypertonic saline solution intensive care
the effects of naltrexone on active crohn's disease

Conditions: Inflammation; Crohn's Disease

Summary: it is hypothesized that the opioid antagonist naltrexone will improve inflammation of the bowel and quality of life in subjects with active crohn's disease compared to placebo. in order to test this hypothesis the following specific aims are proposed: 1. evaluate the effects of low dose naltrexone compared to placebo on the activity of crohn's disease by the following end points: crohn's disease activity index (cdai), pain assessment, laboratory values (crp and esr), endoscopic appearance, histology, and quality of life surveys; 2. examine the effects of naltrexone given over 3 months compared to 6 months for durability of response; 3. determine the safety and toxicity of low dose naltrexone in subjects with active crohn's disease, and 4. study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin levels of subjects on therapy. purpose statement: the purpose of this study is to evaluate the effects of low dose naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this compound in those with active crohn's disease.

study design : the study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study.

Eligibility criteria:
inclusion criteria: * all subjects must give written informed consent * male or female subjects, \> 18 years * patients must have endoscopic, histologic, or radiographic confirmed crohn's disease. * patients must have a crohn's disease activity index (cdai) of at least 220 at baseline * stable doses of medications for crohn's disease over proceeding 4 weeks (for aminosalicylates and steroids: prednisone of 10mg or less daily and entocort 3 mg/ day are allowed), and 12 weeks for azathioprine or 6-mercaptopurine.) exclusion criteria: * subjects with ostomies or ileorectal anastomosis from prior surgical colectomy. * subjects who received infliximab (remicade) within 8 weeks of study screening or humira for 4 weeks. * subjects requiring steroids either intravenously or prednisone \>10mg /day or entocort \> 3 mg daily. * subjects with short-bowel syndrome. * abnormal liver enzymes at screening visit or known hepatitis or cirrhosis * hemoglobin less than 10. * subjects with cancer (other than skin cancer) in past 5 years. * women of childbearing potential unless surgically sterile or using adequate contraception (either iud, oral or deport contraceptive, or barrier plus spermicide), and willing and able to continue contraception for 3 months after the completion of the study. * women who are pregnant or breastfeeding

Keywords: naltrexone ldn ibd inflammatory bowel disease
poc-md mri-based trial in relapsing-remitting multiple scler

Conditions: Relapsing-remitting Multiple Sclerosis; RRMS

Summary: a randomized, multi-center, double-blind, proof-of-concept study to assess the effect of multiple infusions of ain457 (10 mg/kg) versus placebo on disease activity as measured by mri scans over a 24 week period in patients with relapsing-remitting multiple sclerosis


Eligibility criteria:
inclusion criteria: - exclusion criteria: -

Keywords: relapsing-remitting multiple sclerosis rrms
treatment outcome in early diffuse cutaneous systemic sclerosis

Conditions: Early Diffuse Cutaneous Systemic Sclerosis

Summary: the aim of the study is to compare the effectiveness of commonly used immunosuppressant treatments for early diffuse cutaneous systemic sclerosis (ssc).

diffuse cutaneous systemic sclerosis (ssc) is a rare autoimmune disease characterised by excessive connective tissue in the skin (causing skin thickening called 'scleroderma'), muscle, joints and internal organs. a number of different drugs with effects on the immune system (known as 'immunosuppressants') are currently being used by clinicians in the treatment of early diffuse cutaneous ssc, but all can have significant side effects. we want to know whether any one is definitely effective and, if so, which is the most effective.

Eligibility criteria:
inclusion criteria: age \> 18 skin thickening \< 3 years immunosuppressant use \< 4 months proximal skin involvement to face/neck, elbow or knee exclusion criteria: previous use of more than 4 months of methotrexate, mycophenolate mofetil, cyclophosphamide or other immunosuppressive treatments previous use of immunosuppressant therapy other than methotrexate, mycophenolate mofetil or cyclophosphamide within previous months previous stem cell transplantation therapy

Keywords: systemic sclerosis
disruptive behavior management and prevention in hospitalized patients using a behavioral intervention team

Conditions: Behavioral Problem

Summary: the purpose of the proposed study is to evaluate the impact of a behavioral intervention team (bit) on 2 adult units: a general medical (8n); a cardiac/medical stepdown (8s) at vanderbilt university medical center (vumc) with a higher proportion of patients with behavioral health comorbidities.

the bit will provide a proactive psychiatric team that will screen all patients on admission, provide consultation to those meeting established criteria, and recommend interventions to the primary care team for consideration. bit will also serve to model therapeutics tactics in communication and goal setting to the clinical staff. research questions for the proposed study: considering that behavioral health co-morbidity is common among hospitalized medical inpatients and is associated with higher costs of care and staff dissatisfaction, we will ascertain whether the addition of dedicated, trained behavioral intervention team, compared to nursing staff training on trauma informed care and de-escalation techniques provides: 1. meaningful, measureable improvement in the prevention and management of disruptive behavior in the healthcare setting at vumc, and 2. improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior specifically, using a pragmatic, cluster cross-over trial design where the bit crosses between 8n and 8s, we will test the hypothesis that presence of the bit results in: 1. improvement in the prevention and management of patients exhibiting disruptive, threatening or acting out behavior 2. improvement in staff perceptions of their ability to manage patients exhibiting disruptive, threatening or acting out behavior

Eligibility criteria:
inclusion criteria: * all patients admitted to two adult medical surgical units (8n/8s) at vanderbilt university medical center during the study period. * all clinical nurses and staff on 8n/8s employed during the study period. exclusion criteria: * patients admitted to the floor before the bit team has begun the crossover period on the unit.
study of the safeseal(tm) hemostasis patch following percutaneous coronary artery and peripheral vascular interventions

Conditions: Coronary Artery Disease; Peripheral Vascular Disease

Summary: we seek to determine if the use of the safeseal(tm) topical hemostasis patch is associated with reductions in time to hemostasis and time to ambulation compared to standard manual compression after arterial sheath removal following percutaneous coronary and peripheral intervention. we further seek to assess the safety of the safeseal patch compared to manual compression.

a variety of topical hemostasis pads containing procoagulant materials are currently available to accelerate hemostasis after removal of the arterial introducer sheath following coronary and peripheral arterial angioplasty procedures. the effectiveness and safety of these pads, however, remains poorly understood. a total of 150 patients undergoing coronary or peripheral vascular angioplasty through a 6 french arterial sheath will be randomized to sheath removal using manual compression alone or manual compression combined with use of the safeseal(tm) hemostasis patch. sheaths will be removed at an activated clotting time (act) of \<250 seconds, and patients will be kept at bedrest for 2 hours after hemostasis is achieved. the primary endpoint will be time to hemostasis. secondary endpoints witll include time to ambulation and frequency of bleeding complications.

Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years old 2. coronary or peripheral vascular intervention 3. 6 french arterial sheath used 4. overnight hospitalization following procedure exclusion criteria: 1. hematoma or persistent bleeding around the vascular sheath 2. previous av fistula or pseudoaneurysm in the ipsilateral femoral artery 3. history of bleeding diathesis or coagulopathy 4. hemoglobin level \< 9 g/dl 5. inability to ambulate at baseline 6. known allergy to any of the materials used in the safeseal 7. female patients known to be pregnant or lactating 8. evidence of ongoing systemic or cutaneous infection 9. uncontrolled blood pressure following pci (systolic blood pressure \> 180 or diastolic blood pressure \>110) 10. current enrolment in another ongoing investigational drug/device trial.

Keywords: angioplasty, percutaneous transluminalcoronary
overcome biochemical aspirin resistance through cilostazol combination

Conditions: Cerebral Infarction

Summary: this study will recruit 316 ischemic stroke patients taking aspirin. they will be randomly assigned into cilostazol group or placebo group. every patients will take 200mg of cilostazol a day or placebo for 1 month. the primary outcome variable of this study is rate of biochemical aspirin resistance on the ultra rapid platelet function assay-asa.

\[goal\] to reveal the effect and safety of additional cilostazol for overcoming biochemical aspirin resistance. \[trial design\] double-blind, placebo-controlled, randomized, multicenter trial \[participants\] ischemic stroke patients taking aspirin \[methods\] * double-blind, placebo-controlled, randomized, multicenter trial * investigational product: cilostazol 200mg (100mg twice per day) * concomitant medication: aspirin 100 mg per day * medication duration: 1 month \[outcome variables\] primary outcome variable: • the proportion of patients with aspirin reaction units (arus) values ≥550 on the ultra rapid platelet function assay-asa secondary outcome variables: * the proportion of patients with arus values ≥500 on the ultra rapid platelet function assay-asa * arus values * bleeding time (bt) * fatal or major bleeding complications * any bleeding complications

Eligibility criteria:
inclusion criteria: * symptomatic cerebral infarction documented on mri or ct * more than 35 years of age * patients taking aspirin 100mg a day for 2 weeks or more before randomization exclusion criteria: * patients taking any antiplatelets other than aspirin within 2 weeks before randomization * patients taking any anticoagulants within 2 weeks before randomization * patients taking thrombolytic therapy within 2 weeks before randomization * patients taking any nsaids within 2 weeks before randomization * patients who need to take nsaids regularly (e.g. rheumatic arthritis). * bleeding diathesis * chronic liver disease (alt \> 100 or ast \> 100) or chronic renal disease (creatinine \> 3.0mg/dl) * anemia (hemoglobin \< 10mg/dl) or thrombocytopenia (platelet count less than 100,000/mm3) * pregnant or lactating patients * patients scheduled for angioplasty or revascularization procedures within 4 weeks * patients scheduled for any surgery or invasive procedures within 4 weeks * patients having acute coronary syndrome

Keywords: infarction, cerebral cilostazol aspirin resistance
study of subclinical viral infection

Conditions: Kidney Transplantation; Kidney Failure, Chronic

Summary: chronic allograft injury is the leading cause of graft loss in renal transplantation. the shortage of available kidneys for transplantation has reached crisis levels with increasing numbers of waiting list mortalities. strategies to prolong graft survival are urgently needed. the pediatric and young adult transplant population is one in which repeat transplantation is inevitable and therefore, this group is one who will especially benefit from intervention to prolong graft survival. the hypothesis of this proposal is that subclinical viral infection is a modifiable risk factor in the pathogenesis of chronic allograft injury. the young age of the proposed study population is an ideal one to evaluate this objective due to the high prevalence of seronegative recipients. the studies outlined will determine the temporal relationship betweween subclinical viremia, renal allograft infection and allograft injury. this will be the first prospective study in renal transplant recipients to systematically monitor subclinical viral infection both in peripheral blood and in the renal allograft with concurrent quantitative measures of renal function, allograft fibrosis, and innate immune activation. the investigators have chosen these 3 outcomes because they evaluate a spectrum of renal allograft injury and represent different stages - from early to late - in the pathophysiology that leads to renal allograft dysfunction. in addition, the role of virus specific t cell immune responses in the control of subclinical viral infection and associated allograft injury will be determined. these data are critical as they will provide insights into the pathogenesis of injury and will guide development of interventions strategies. importantly, the current treatment strategies for viral disease do not prevent subclinical viral infection. thus, the results of this study may identify that prevention, prophylaxis and/or treatment of subclinical viral replication as a long term strategy to prevent chronic allograft injury and prolong graft survival.


Eligibility criteria:
inclusion criteria: * subject and/or parent guardian must be able to understand and provide informed consent or assent * male or female, seattle children's hospital participants must be 1-\<21 yrs and university of washington medical center participants 18-25yrs. * diagnosed with end stage renal disease (esrd) exclusion criteria: * inability or unwillingness of subject and/or parent guardian to provide informed consent * pregnancy

Keywords: kidney transplantation subclinical viral infection renal allograft injury
vaccine therapy in preventing cervical cancer in patients with cervical intraepithelial neoplasia

Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia Grade 3; Human Papilloma Virus Infection

Summary: vaccines made from antigens may make the body build an immune response to kill abnormal cervical cells and may be effective in preventing cervical cancer. randomized phase ii trial to study the effectiveness of vaccine therapy in preventing cervical cancer in patients who have cervical intraepithelial neoplasia

primary objectives: i. determine the efficacy of sgn-00101, in terms of complete histologic regression, in patients with grade iii cervical intraepithelial neoplasia. ii. determine the toxicity of this drug in these patients. secondary objectives: i. determine change in lesion size in these patients after treatment with this drug. ii. compare histologic response before and after treatment with this drug in these patients. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. arm i: patients receive sgn-00101 subcutaneously once on weeks 1, 4, and 8 in the absence of disease progression. arm ii: patients receive standard care. at week 15, all patients undergo large loop excision of the transformation zone under colposcopy. patients are followed at 19 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. projected accrual: a total of 28-84 patients (14-42 per treatment arm) will be accrued for this study within 12-48 months.

Eligibility criteria:
inclusion criteria: * histologically confirmed grade iii cervical intraepithelial neoplasia * confirmed by biopsy or colposcopy * positive for human papilloma virus 16 * no endocervical glandular dysplasia * no adenocarcinoma in situ * performance status - gog 0-2 * no life-threatening or serious hematological disorder * no life-threatening or serious hepatic disorder * no life-threatening or serious renal disorder * no life-threatening or serious cardiac disorder * no life-threatening or serious respiratory disorder * hiv negative * must be immunocompetent * no history of autoimmune disease * no life-threatening or serious immunological disorder * no prior or concurrent severe allergic disease * no concurrent human papilloma viral infection other than type 16 * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no life-threatening or serious gastrointestinal disorder * no life-threatening or serious endocrine disorder * no invasive malignancy within the past 5 years except nonmelanoma skin cancer * no concurrent chronic or systemic steroids * no prior organ transplantation * no prior cancer therapy that would preclude study therapy
correlation of chronic pancreatitis pathology features with endoscopic ultrasound (eus) criteria

Conditions: Chronic Pancreatitis

Summary: in this research project the investigators intend to find out if endoscopic ultrasound (eus) criteria for diagnosing chronic pancreatitis can be correlated with pathologic characteristics of tissues taken from pancreas of patients with suspected chronic pancreatitis. this will be a retrospective study which will examine results from biopsy specimens and endoscopic ultrasound findings in suspected chronic pancreatitis.


Eligibility criteria:
inclusion criteria: * will include all patients who consented to have both eus and had biopsy taken for tissue diagnosis. exclusion criteria: * will exclude patients who are less than 18 years

Keywords: chronic pancreatitis
igf-1 therapy in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: 28 week pilot study to examine the efficacy of recombinant human igf-1 on body weight and composition in adults with cystic fibrosis.

28 week, double blind, cross over study to determine the efficacy of rhigf-1 on body weight and body composition in patients with cystic fibrosis.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis as proven by either sweat chloride or dna analysis. * age \>= 18 yr. * tanner stage: femake breasts: 4-5 male genitalia: 4-5 exclusion criteria: * hemoglobin a1c \> 8.5 % * diabetic retinopathy * obstructive sleep apnea * respiratory failure requiring mechanical ventilation. * status post pulmonary transplantation. * concurrent or recent (within past 6 months) receipt of human growth hormone. * history of adverse side effects to growth hormone other than carbohydrate intolerance. * pregnancy or attempting pregnancy. * women who are breast feeding. * sexually active women who refuse to use or are incapable of responsibly using reliable contraception. * proven non compliance with medical regimens. * inability or refusal to take subcutaneous injections. * known allergy to components in the igf-i preparation.

Keywords: body weight body composition pulmonary function carbohydrate tolerance